The FDA has issued guidance for industry and FDA staff on device postmarket surveillance (PS), which consolidates three separate documents into a single, comprehensive document. The guidance supersedes "Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies," "Guidance on Procedures for Review of Postmarket Surveillance Submissions," and "Guidance on Criteria and Approaches for Postmarket Surveillance."
In a question-and-answer section, the guidance includes detailed information on how the FDA learns of postmarket problems or issues with a medical device, how it determines whether to impose PS under section 522, what criteria considers in making that determination, and how it notifies companies they are required to conduct PS of a device. The guidance also addresses controlled clinical trials for PS plans, the responsibilities of review team members, and the timeline for review of submissions.
The guidance can be viewed at http://www.fda.gov/cdrh/osb/guidance/316.pdf (http://www.fda.gov/cdrh/osb/guidance/316.pdf).